Intra-aortic balloon counterpulsation with concurrent hypothermia

ABSTRACT

Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient&#39;s body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient&#39;s vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

The applicant(s) hereby request(s) the filing of the continuation patentapplication under 37 CFR §1.53(b) is a divisional of application Ser.No. 10/015,220, filed Oct. 26, 2001 now U.S. Pat. No. 6,800,068.

FIELD OF THE INVENTION

This invention relates generally to methods and apparatus for medicaltreatment and more particularly to methods, devices and systems foradministering intra-aortic balloon counterpulsation concurrently withthe use of a heat exchange catheter for inducing and maintaininghypothermia in at least a portion of the patient's body (e.g., cardiachypothermia, cardiac & cerebral hypothermia, etc.)

BACKGROUND OF THE INVENTION

A. Intra-Aortic Balloon Pump (IABP) Counterpulsation

An intra-aortic balloon pump (IABP) is a device that may be used to a)increase myocardial blood flow in patients whose cardiac output iscompromised due to heart failure or cardiac insufficiency and b)decreases the heart's workload, through a process calledcounterpulsation.

During each cardiac cycle, the human heart expels oxygenated blood intothe aorta as its left ventricle contracts (i.e., during systole) and,thereafter, receives a backflow of arterial blood into the coronaryarteries as its left ventricle relaxes (i.e., during diastole). Thesystolic pumping of blood into the aorta requires the heart muscle toovercome the static pressure of blood that is already in the aorta. Ahealthy heart is typically able to perform both of these functionseffectively. However, a weakened or failing heart may be unable toperform the work required to fully overcome the static pressure of bloodalready in the aorta, thereby resulting in less ejection of oxygenatedblood into the aorta during systole and less backflow of oxygenatedblood into the coronary arteries during diastole.

Intra-aortic balloon counterpulsation is a technique which causes morearterial blood to enter the coronary arteries (and thus more blood flowto the heart muscle) during diastole (less flow work) and decreases theamount of work that the heart must perform during systole (less pressurework). By increasing coronary blood flow, the myocardium receives moreoxygen, thereby allowing the heart to pump more effectively andincreasing the cardiac output that occurs with each heartbeat (i.e., the“stroke volume”).

The IABP comprises a) a balloon catheter that is percutaneouslyinsertable into the patient's aorta and b) a control console that isattached to the balloon catheter. A computer or controller within thecontrol console receives the patient's electrocardiogram (ECG). Inresponse to the ECG signal, the controller causes the intra-aorticballoon to be inflated during diastole (when the heart muscle relaxed)resulting in increased back pressure within the aorta and increasedblood flow into the coronary arteries, and deflated during early systole(during a phase known as “isometric contraction”) resulting in areduction of intra-aortic pressure against which the heart must pump. Inthis way, the IABP improves blood flow to the heart muscle and reducesthe workload of the heart muscle. Additionally, IABP counterpulsationhas been demonstrated to improve peripheral or systemic arterialperfusion. Although the mechanism by which IABP counterpulsationimproves peripheral or systemic profusion is not well understood, it isbelieved that inflation of the intra-aortic balloon during diastoleserves to facilitate peripheral runoff (sometimes referred to as theintrinsic “Windkessel” effect) which then augments peripheral perfusion.

Preferably, the gas used to inflate the balloon is either carbon dioxide(which has fewer consequences in the rare event of a balloon bursting)or helium (which has the fastest ability to travel or diffuse).

B. The Effects of Hypothermia on Cardiac Function

Mild hypothermia has been shown to both increase the contractility ofthe heart muscle and to reduce its metabolic requirements. Indeed, ifthe hypothermia is systemic, the metabolic demands of the entire bodyare generally reduced, so that the demands placed on the heart may bereduced. Additionally, when the patient's body temperature is reducedand maintained 1° C. or more below normothermic (e.g., less than 36° C.in most individuals), such that the output of the heart increases, thecondition and function of the heart muscle may improve significantly dueto the combined effects of increased bloodflow to the heart, atemporarily decreased metabolic need and decreased metabolic wasteproducts.

One method for inducing hypothermia of the heart or entire body isthrough the use of a heat exchange catheter that is inserted into ablood vessel and used to cool blood flowing through that blood vessel.This method in general is described in U.S. Pat. No. 6,110,168 toGinsburg, which is expressly incorporated herein by reference. Variousheat exchange catheters useable for achieving the endovascular coolingare described in U.S. Pat. No. 5,486,208 (Ginsburg), PCT InternationalPublication WO OO/10494 (Machold et al.), U.S. Pat. No. 6,264,679(Keller et al.), U.S. patent application Ser. No. 09/777,612, all ofwhich are expressly incorporated herein by reference. Other endovascularcooling catheters may be employed to practice this patented method, forexample U.S. Pat. No. 3,425,484 (Dato), U.S. Pat. No. 5,957,963 (DobakIII) and U.S. Pat. No. 6,126,684 (Gobin, et al.), provided that they areable to provide adequate hypothermia to the diseased heart.

The potential for shivering is present whenever a patient is cooledbelow that patient's shivering threshold, which in humans is generallyabout 35.5° C. When inducing hypothermia below the shivering threshold,it is very important to avoid or limit the shivering response. Theavoidance or limiting of the shivering response may be particularlyimportant in patients who suffer from compromised cardiac functionand/or metabolic irregularities. An anti-shivering treatment may beadministered to prevent or deter shivering. Examples of effectiveanti-shivering treatments are described in U.S. Pat. No. 6,231,594 (Daeet al.).

SUMMARY OF THE INVENTION

The present invention provides a catheter device that is insertable intothe aorta of a human or veterinary patient. Such catheter devicecomprises a) a balloon that is useable for performing intra-aorticcounterpulsation and b) a heat exchanger for exchanging heat with thepatient's flowing blood so as to induce hypothermia of all or a portionof the patient's body.

Further in accordance with the invention, the catheter device of theforegoing character may be used in combination with driving and controlapparatus connected to the catheter for a) causing and controlling theinflation/deflation of the intra-aortic balloon and b) cool or warmingthe heat exchanger to bring about and maintain the desired hypothermiaof all or a portion of the patient's body. The driving and controlapparatus may be positioned extracorporeally and may be housed in one ormore consoles that are positioned near the patent's bed. Preferably, atleast the patient's heart (and in some cases the brain, other portionsof the body or the entire body) will be maintained at a temperature 1°C. or more below normothermic (e.g., less than 36° C. in most humans).

Still further in accordance with the invention, the heat exchanger ofthe catheter device may comprise less than the entire length of thecatheter.

Still further in accordance with the invention, the heat exchanger ofthe catheter may comprise or be associated with one or moreflow-disrupting surface(s) which increase the effective heat exchangesurface area and/or alter or disrupt the laminarity of blood flowadjacent to the heat exchanger in a manner that causes some turn over ofblood within heat exchange proximity to the heat exchanger and aresultant increase in the efficiency of the heat exchange process.

Still further in accordance with the invention, the heat exchanger ofthe catheter may be of a flowing fluid type, wherein a fluidic heatexchange medium (e.g., saline solution) is circulated through thecatheter and through the heat exchanger. In some embodiments, suchflowing fluid type heat exchanger may comprise a flexible structure(e.g., a balloon) which expands or become taut when the heat exchangefluid is circulated therethrough. In some of these embodiments, the heatexchange balloon may be multi-lobed and/or may be curved or twisted(e.g., helical) in configuration. Also, in some embodiments whichutilize the flowing fluid type heat exchanger, a wall or surface whichseparates the patient's flowing blood from the heat exchange mediumbeing circulated through the heat exchanger may comprise a metal toprovide for provide for improved heat transmission between the blood andthe heat exchange medium.

Still further in accordance with the invention, in some embodiments theheat exchanger and the counterpulsation balloon may comprise one in thesame structure. In this regard, the counterpulsation balloon may beinflated and deflated with a cold gas such that the counterpulsationballoon itself serves as a heat exchanger (in addition to performing itscounterpulsation function). Alternatively, a channel or space forrecirculation of heat exchange medium (e.g., cooled saline solution) maybe formed on or in a wall or portion of the counterpulsation balloonsuch that heat exchange medium is circulated therethrough as thecounterpulsation balloon undergoes repeated inflation and deflation.

Still further in accordance with the invention, in some embodiments, theheat exchanger may be located more distally on the catheter than thecounterpulsation balloon, such that when the catheter is advanced inretrograde fashion into the patient's aorta to a position where thecounterpulsation balloon is properly positioned to perform itscounterpulsation function (e.g., within the thoracic aorta), the heatexchanger will be positioned superior to the counterpulsation balloon(e.g., within the aorta between the heart and the counterpulsationballoon).

Still further in accordance with the invention, in some embodiments, theheat exchanger may be located more proximally on the catheter than thecounterpulsation balloon, such that when the catheter is advanced inretrograde fashion into the patient's aorta to a position where thecounterpulsation balloon is properly positioned to perform itscounterpulsation function (e.g., within the thoracic aorta), the heatexchanger will be located inferior to the counterpulsation balloon(e.g., within the aorta between the counterpulsation balloon and theiliac bifurcation.

Still further in accordance with the invention, the method may becarried out using separate intra-aortic balloon counterpulsationcatheter and heat exchange catheters. In such two-catheter embodimentsof the method, the heat exchange catheter is separate from theintra-aortic balloon counterpulsation catheter and thus need notnecessarily be positioned in the aorta along with the intra-aorticballoon counterpulsation catheter. Rather, the separate heat exchangecatheter may be positioned in any suitable blood vessel (vein or artery)to effect cooling of the desired portion of the patient's body and/orthe entire patient's body. Examples of separate heat exchange cathetersand related control systems are described in U.S. Pat. Nos. 5,486,208(Ginsburg), 6,264,679 (Keller et al.), 3,425,484 (Dato), 5,957,963(Dobak III) 6,126,684 (Gobin, etal.), 6,264,679 (Keller et al.) and5,531,776 (Ward et al.), as well as in PCT International Publication WOOO/10494 (Radiant Medical, Inc.) and copending U.S. patent applicationSer. No. 09/777,612, the entireties of which are expressly incorporatedherein by reference.

Still further in accordance with the invention, the method may furthercomprise the step of administering to the patient an anti-shiveringtreatment such as those described in U.S. Pat. No. 6,231,594 (Dae etal.), the entirety of which is expressly incorporated herein byreference.

Still further aspects and elements of the present invention will becomeapparent to those skilled in the art upon reading and considering thedetailed descriptions of examples set forth herebelow and in theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-4 b, attached hereto, show examples or embodiments of themethods and apparatus of the present invention, as follows:

FIG. 1 is a diagram of a human body showing relevant portions of thecardiovascular system including the heart (H), aorta (A) and femoralartery (FA).

FIG. 2 is a cut-away view of the heart (H) and great vessels, showingthe coronary arteries (CA), aortic arch (AA), brachiocephalic trunk(BCT), left common carotid artery (LCC) and left subclavian artery(LSA).

FIG. 3 is a schematic diagram of an intra-aortic balloon/heat exchangercatheter (10) of the present invention positioned withing the aorta (A)and connected to driving/control apparatus (30) that control and operatethe catheter's counterpulsation balloon (14) and heat exchanger (16).

FIG. 3 a is a cut away view of portion 3 a of FIG. 3, showing oneexample of the manner in which the heat exchanger 16 my be constructed.

FIG. 3 b is a cross sectional view through line 3 b-3 b of FIG. 3.

FIG. 4 is a schematic diagram of the thoracic aorta of a human patientwherein an alternative embodiment of a balloon/heat exchanger catheter(10 a) of the present invention is positioned.

FIG. 4 a is a schematic diagram of the thoracic aorta of a human patientwherein yet another alternative embodiment of a balloon/heat exchangercatheter (10 a) of the present invention is positioned.

FIG. 4 b is an enlarged sectional view of the heat exchanger of thecatheter (10 b) shown in FIG. 4 a.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

The following detailed description is provided for the purpose ofdescribing only certain embodiments or examples of the invention and isnot intended to describe all possible embodiments and examples of theinvention.

With reference to FIGS. 1-4 b, a balloon/heat exchanger catheter 10, 10a, 10 b of the present invention generally comprises an elongatecatheter body 12, 12 a, 12 b having a heat exchanger 16, 16 a, 16 b anda counterpulsation balloon 14, 14 a, 14 b positioned thereon. As may beseen from the cross-section of FIG. 3B, the catheter body 12, 12 a, 12 bproximal to the heat exchanger 16, 16 a, 16 b comprises a gasinflation/deflation lumen 52 through which gas or other suitable fluidis alternately infused and withdrawn to effect inflation and deflationof the counterpulsation balloon 14, 14 a, 14 b as well as heat exchangefluid inflow and outflow lumens 54, 56 through which heat exchange fluidis circulated through the heat exchanger 16, 16 a, 16 b. Preferably, theheat exchange fluid inflow lumen 54 is connected to the proximal end ofthe heat exchanger 16, 16 a, 16 b and the heat exchange fluid outflowlumen 56 is connected to the distal end of the heat exchanger 16, 16 a,16 b, thereby causing the heat exchange fluid to flow through the heatexchanger 16, 16 a, 16 b in a direction opposite the direction in whichblood is flowing through the patient's aorta.

In some embodiments, such as that shown in FIG. 3, the counterpulsationballoon 14, may be positioned on a portion of the catheter body 12 thatis distal to the heat exchanger 16. In other embodiments, such as thoseshown in FIGS. 4 a and 4 b, the counterpulsation balloon 14 a, 14 b maybe positioned on a portion of the catheter body that is proximal to theheat exchanger 16 a, 16 b. Additionally, hybrids or combinations ofthese designs may also be employed wherein one or more heat exchangersmay be positioned proximal and distal to the counterpulsation balloon.

The catheter body 12, 12 a, 12 b has multiple lumens as needed to permitthe passage of balloon inflation fluid (e.g., carbon dioxide or helium)into and out of the counterpulsation balloon 14, 14 a, 14 b and thepassage of energy or heated/cooled thermal exchange fluid into the heatexchanger 16, 16 a, 16 b. In this regard, the heat exchanger preferablycomprises at least one heat exchange surface that is in contact with aheat exchange lumen through which a heated or cooled heat exchangemedium (e.g., saline solution) may be passed. In the particularembodiments shown in the figures, the heat exchange surface comprisesthe blood-contacting outer surfaces of helical tubes 20 (FIGS. 3, 3 aand 4) or straight tubes 48 through which the heat exchange medium iscirculated. In other embodiments, not shown, the heat exchanger maycomprises a thermoelectric element or chemically cooled member mountedwithin or on the catheter body and connected to the extracorporealdrive/control apparatus 30 by a wire or other communication pathway thatextends through the catheter body 12 to deliver electrical current,chemical activators or other forms of energy to the heat exchanger forthe purpose of causing the heat exchanger to warm and/or cool as neededto maintain the desired temperature.

The drive/control apparatus 30 is useable to drive and control the heatexchanger 16, 16 a, 16 b and the counterpulsation balloon 14, 14 a, 14b. With respect to controlling and driving of the heat exchanger 16, 16a, 16 b, the drive/control apparatus 30 comprises a heater/cooler 34 forcausing the heat exchanger 16, 16 a, 16 b, to heat or cool as needed.Generally, the drive/control apparatus 30 comprises a controller 32 suchas a microprocessor or computer, a heater/cooler 34 for heating andcooling the heat exchanger 16, 16 a, 16 b, a temperature monitoringapparatus for providing a temperature signal 38 to the controller 32 andan electrocardiogram (ECG) monitoring apparatus for providing an ECGsignal to the controller 32.

Specific examples of the types of apparatus that comprise theheater/cooler 34 and the portions or function of the controller 32 thatcontrol the heat exchanger 16, 16 a, 16 b and temperature probes thatprovide the temperature signal 40 are described in theabove-incorporated PCT International Publication WO OO/10494. It ispresently preferred that the patient's esophageal temperature bemeasured by a temperature probe positioned in the esophagus and that thetemperature signal received by the controller 32 receive a signal 40indicative of such monitored esophageal temperature. A desired targettemperature is set or inputted into the controller 32 and the controller32 is programmed to cause the heater/cooler to heat or cool the heatexchanger 16, 16 a, 16 b to maintain the monitored temperature at ornear the desired target temperature.

With respect to driving (e.g., inflating and deflating) and controllingof the counterpulsation balloon 14, 14 a, 14 b, the drive/controlapparatus 30 comprises a pump (IABP) for pumping inflation fluid intoand out of the counterpulsation balloon at specific times in relation tothe cardiac cycle or ECG. Specific examples of the IABP and the othercomponents/functions of the controller 32 used to drive and control thecounterpulsation balloon 14, 14 a, 14 b and means for providing andprocessing the ECG signal 40 are described in U.S. Pat. Nos. 3,504,662(Goetz et al.) and 3,504,662 (Jones), the entireties of which areexpressly incorporated herein by reference.

It will be appreciated that, in embodiments such as those shown in FIGS.4-4 b, wherein the heat exchanger 16 a, 16 b is located on the catheterdistal to the counterpulsation balloon 14 a, 14 b, it may be necessaryor desirable for the heat exchanger 16 a, 16 b to reside within the archof the aorta AA in order for the counterpulsation balloon 14 a, 14 b tobe optimally positioned within the thoraco-abdominal aorta A inferior tothe left subclavian artery LSA, but still superior to other branches ofthe aorta such as the superior mesenteric and renal arteries. In suchcases, it may be desirable to construct or utilize the heat exchanger 16a, 16 b in a way that avoids blocking or disrupting flow into thecoronary ostia CO, brachiocephalic trunk BCT, left common carotid arteryLCA and/or left subclavian artery LSA. As shown in FIG. 4, this may beaccomplished by simply causing the heat exchanger 16 a to be smaller indiameter than the lumen of the aortic arch AA such that flow spaceexists around the heat exchanger 16 and the coronary ostia CO,brachiocephalic trunk BCT, left common carotid artery LCA and/or leftsubclavian artery LSA remain unobstructed. Another approach, as shown inFIGS. 4 a-4 b, is to construct the heat exchanger 16 b such that itsheat exchange elements 48, when fully deployed and operational, cannotobstruct or block the coronary ostia CO, brachiocephalic trunk BCT, leftcommon carotid artery LCA and/or left subclavian artery LSA. In theparticular embodiment shown in FIGS. 4 a-4 b, the distal portion of thecatheter body 12 b is preformed to a “J” shape and the heat exchanger 16b comprises a plurality of arcuate heat exchange tubes 48 that aredisposed on the underside US of the J shaped catheter body 12 such thatthe heat exchange tubes 48 remain adjacent the wall of the aorta A thatis opposite the brachiocephalic trunk BCT, left common carotid arteryLCA and/or left subclavian artery LSA.

The cooling of the patient's body may cause some shivering to occur, ifthe patient's core body temperature is cooled to less than about 35.5°C. In such cases, it may be desirable to administer an anti-shiveringtreatment to prevent or lessen the shivering and enhance the patient'scomfort. Such anti-shivering treatment may comprise the mere applicationof warmth to the patient's skin as may be accomplished by a warmingblanket of the type commonly used in hospitals. Alternatively oradditionally, such anti-shivering treatment may comprise theadministration of drugs or agents to minimize or prevent the shiveringresponse. Examples of agents that are useable for this purpose aredescribed in the above-incorporated U.S. Pat. No. 6,231,594 (Dae etal.). For example, an anti-shivering treatment may comprise the stepsof:

-   -   (i) administering an initial bolus dose of a first        anti-thermoregulatory response agent to the patient (for example        an oral dose of a serotonin 5 HT1a receptor agonist such as 60        mg of buspirone);    -   (ii) administering a subsequent dose of a second        anti-thermoregulatory response agent to the patient (for example        an initial intravenous dose of an μ opioid receptor agonist such        as 50 mg of meperidine administered by slow push followed by a        similar second dose); and    -   (iii) administering a further dose of the second        anti-thermoregulatory response agent by constant IV        administration (for example, constant IV administration of about        25 mg/hr of meperidine).        Alternatively, another anti-shivering treatment that may be more        suitable for longer term use (e.g., more than 24 hours)        comprises the following steps:    -   (i) administering a first dose of an anti-thermoregulatory        response agent to the patient (for example an intravenous dose        of an μ opioid receptor agonist such as 50 mg of meperidine        administered by slow push and infused over about 5 minutes);    -   (ii) administering a second dose of the anti-thermoregulatory        response agent to the patient (for example, about 15 minutes        after the initial administration of meperidine, an additional 50        mg of meperidine is administered by slow IV push);    -   (iii) administering a third dose of the anti-thermoregulatory        response agent by constant IV administration (for example,        constant IV administration of about 25 mg/hr of meperidine        maintained for the duration of the time that the patient's        temperature is below the shivering threshold);    -   (iv) an intravenous temperature control catheter of the general        type described above is introduced into the vasculature of the        patient and the heat exchange region of the catheter is placed        in the IVC and cooling is begun at the maximum rate. The patient        is thereafter maintained at a therapeutically low temperature        even below the shivering threshold.

Another class of anti-shivering drugs that may be particularly usefulare the alpha-adrenergic receptor agonists, such as dexmedetomidine andclonidine.

Although several illustrative examples of means for practicing theinvention are described above, these examples are by no means exhaustiveof all possible means for practicing the invention. For example, asdescribed in the Summary of the Invention, instead of using acombination heat exchange/IABP catheter as shown in the drawings, astandard or conventional IABP catheter may be used and a separate heatexchange catheter may be deployed in the aorta or elsewhere, such as inthe inferior vena cava or venous vasculature, to effect the desiredcooling of the patient's heart, other body parts or entire body. Othermodifications to the embodiment shown in the drawings are also possible.The scope of the invention should therefore be determined with referenceto the appended claims, along with the full range of equivalents towhich those clams are entitled.

1. A heat exchange/intra-aortic counterpulsation system comprising: anelongate heat exchange/counterpulsation catheter having a proximal end,a distal end and a plurality of lumens; a counterpulsation balloonlocated on the catheter and useable for effecting intra-aortic ballooncounterpulsation; a heat exchanger located on the catheter that receivesa heat exchange fluid through a lumen of the catheter and has a heatexchange surface for exchanging heat with a patient's flowing blood whenpositioned within the vasculature of the patient to substantially raiseor lower the patient's body temperature without causing the heatexchange fluid to enter the patient's vasculature; at least onedrive/control apparatus to i) control inflation/deflation of thecounterpulsation balloon in response to received electrocardiogramsignals to thereby effect intraortic counterpulsation and ii) deliverheat exchange fluid to the heat exchanger to vary the temperature of theheat exchange surface in response to received temperature signalsrepresentative of patient body temperature; a temperature monitoringapparatus for providing temperature signals representative of patientbody temperature to the drive/control apparatus; and anelectrocardiogram monitoring apparatus for providing electrocardiogramsignals to the drive/control apparatus.
 2. A device according to claim 1wherein the heat exchanger comprises a heat exchanger through which heatexchange fluid is circulated.
 3. A device according to claim 2 whereinsaid heat exchanger comprises a heat exchange balloon.
 4. A deviceaccording to claim 3 wherein the heat exchanger comprises a single-lobedheat exchange balloon.
 5. A device according to claim 3 wherein the heatexchanger comprises a multi-lobed heat exchange balloon.
 6. A deviceaccording to claim 3 wherein the heat exchange balloon and thecounterpulsation balloon comprise a single balloon that is located onthe catheter and useable for both counterpulsation and heat exchange. 7.A device according to claim 1 wherein at least a portion of the heatexchanger is metallic.
 8. A device according to claim 1 wherein the heatexchanger comprises a heat exchange surface and wherein the devicefurther comprises a flow disruption surface associated with the heatexchange surface, the flow disruption surface being configured todisrupt the laminarity of blood flow adjacent to the heat exchangesurface, thereby enhancing the efficiency by which the heat exchangerexchanges heat with the flowing blood.
 9. A device according to claim 1wherein the counterpulsation balloon is positioned at a first locationon the catheter and the heat exchanger comprises a heat exchange surfacelocated at a second location on the catheter.
 10. A device according toclaim 9 wherein the first location is closer to the distal end of thecatheter than the second location.
 11. A device according to claim 9wherein the second location is closer to the distal end of the catheterthan the first location.
 12. A device according to claim 9 wherein theheat exchanger and the counterpulsation balloon comprise a singleballoon which is a) configured and useable to effect intra-aorticcounterpulsation and b) receives a heat exchange medium such that heatis exchanged between the heat exchange medium and the blood, through atleast a portion of the balloon.